DICLOFENAC SODIUM

Product NDC
68462-355
11-digit product format
684620355
Labeler code
68462
Product ID
68462-355_6c2982e4-c4a4-4985-82d1-e418c5e055e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
GLENMARK PHARMACEUTICALS INC., USA
Application
ANDA208301
Marketing category
ANDA
Marketing start
2016-09-13
Substance
DICLOFENAC SODIUM
Active strength
30 mg/g
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208301-001DICLOFENAC SODIUMDICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A208301-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133f01610625f2…
2019-09-15 20:21 UTC2019-09A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208301-001DICLOFENAC SODIUM3%GEL / TOPICALAB2016-09-13cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A208301-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208301-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208301-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208301-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208301-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208301-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208301-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208301-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208301-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208301-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208301-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208301-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208301-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208301-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208301-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208301-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208301-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208301-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208301-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208301-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208301-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208301-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208301-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208301-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208301-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208301-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208301-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208301-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208301-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208301-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208301-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208301-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208301-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208301-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208301-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208301-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208301-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208301-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208301-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208301-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
DICLOFENAC SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM30 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855642Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
dab3ae60-0135-43b3-a1d0-8752720af82aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-355-94DICLOFENAC SODIUM1 in 1 CARTONGEL18
68462-355-94DICLOFENAC SODIUM100 g in 1 TUBEGEL1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-355-94GM - Gram68462-355b0abb1b1-6e73-4b07-b403-a3191d52e8d812016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-355DICLOFENAC SODIUM GEL [GLENMARK PHARMACEUTICALS INC., USA]7Current NDC, Legacy NDC, 2 package rows20250121_dab3ae60-0135-43b3-a1d0-8752720af82a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DICLOFENAC SODIUMDICLOFENAC SODIUMHAWAII REPACK, INCea113a58-c7ed-4768-9777-93d9b166dfbe2026-07-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMREMEDYREPACK INC.96f8c42c-db34-43b0-a891-33dd8e39e74f2026-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.5d0a4b41-afbf-45e7-bb1c-587d72314ee02026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
Diclofenac Sodium GelDICLOFENAC SODIUM GELDirect_Rxe82e4d34-bdaa-b950-e053-2995a90a29f12026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMNuCare Pharmaceuticals,Inc.06862cf2-9537-6661-e063-6294a90a20842026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMGLENMARK PHARMACEUTICALS INC., USAdab3ae60-0135-43b3-a1d0-8752720af82a2025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
ndc (product): 68462-355
Diclofenac SodiumDICLOFENAC SODIUMAdvanced Rx Pharmacy of Tennessee, LLCf1892aae-7267-3b4c-e053-2995a90a88022024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMProficient Rx LPf19bf286-f4dd-4491-90c3-9f87130719032023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301
DICLOFENAC SODIUMDICLOFENAC SODIUMAsclemed USA, Inc.57d8513a-820a-46c5-b0c8-5aa1811b0e882020-10-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208301
application number: ANDA208301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855642diclofenac sodium 3 % Topical GelPSN96f8c42c-db34-43b0-a891-33dd8e39e74f10
855642diclofenac sodium 3 % Topical GelPSN5d0a4b41-afbf-45e7-bb1c-587d72314ee010
855642diclofenac sodium 0.03 MG/MG Topical GelSCD96f8c42c-db34-43b0-a891-33dd8e39e74f10
855642diclofenac sodium 0.03 MG/MG Topical GelSCD5d0a4b41-afbf-45e7-bb1c-587d72314ee010
855642diclofenac sodium 3 % Topical GelSY96f8c42c-db34-43b0-a891-33dd8e39e74f10
855642diclofenac sodium 3 % Topical GelSY5d0a4b41-afbf-45e7-bb1c-587d72314ee010
855642diclofenac sodium 3 % Topical GelPSNdab3ae60-0135-43b3-a1d0-8752720af82a8
855642diclofenac sodium 0.03 MG/MG Topical GelSCDdab3ae60-0135-43b3-a1d0-8752720af82a8
855642diclofenac sodium 3 % Topical GelSYdab3ae60-0135-43b3-a1d0-8752720af82a8
855642diclofenac sodium 3 % Topical GelPSNa90e04dc-8ede-4852-9ea5-45bd249dfa1f5
855642diclofenac sodium 0.03 MG/MG Topical GelSCDa90e04dc-8ede-4852-9ea5-45bd249dfa1f5
855642diclofenac sodium 3 % Topical GelSYa90e04dc-8ede-4852-9ea5-45bd249dfa1f5
855642diclofenac sodium 3 % Topical GelPSNe82e4d34-bdaa-b950-e053-2995a90a29f14
855642diclofenac sodium 0.03 MG/MG Topical GelSCDe82e4d34-bdaa-b950-e053-2995a90a29f14
855642diclofenac sodium 3 % Topical GelSYe82e4d34-bdaa-b950-e053-2995a90a29f14
855642diclofenac sodium 3 % Topical GelPSN06862cf2-9537-6661-e063-6294a90a20843
855642diclofenac sodium 3 % Topical GelPSNf1892aae-7267-3b4c-e053-2995a90a88023
855642diclofenac sodium 0.03 MG/MG Topical GelSCDf1892aae-7267-3b4c-e053-2995a90a88023
855642diclofenac sodium 0.03 MG/MG Topical GelSCD06862cf2-9537-6661-e063-6294a90a20843
855642diclofenac sodium 3 % Topical GelSY06862cf2-9537-6661-e063-6294a90a20843
855642diclofenac sodium 3 % Topical GelSYf1892aae-7267-3b4c-e053-2995a90a88023
855642diclofenac sodium 3 % Topical GelPSN1bb676f9-243a-4ae7-b4db-815608e017392
855642diclofenac sodium 0.03 MG/MG Topical GelSCD1bb676f9-243a-4ae7-b4db-815608e017392
855642diclofenac sodium 3 % Topical GelSY1bb676f9-243a-4ae7-b4db-815608e017392
855642diclofenac sodium 3 % Topical GelPSN57d8513a-820a-46c5-b0c8-5aa1811b0e881
855642diclofenac sodium 3 % Topical GelPSNf19bf286-f4dd-4491-90c3-9f87130719031
855642diclofenac sodium 0.03 MG/MG Topical GelSCD57d8513a-820a-46c5-b0c8-5aa1811b0e881
855642diclofenac sodium 0.03 MG/MG Topical GelSCDf19bf286-f4dd-4491-90c3-9f87130719031
855642diclofenac sodium 3 % Topical GelSY57d8513a-820a-46c5-b0c8-5aa1811b0e881
855642diclofenac sodium 3 % Topical GelSYf19bf286-f4dd-4491-90c3-9f87130719031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-355-94684620355941 TUBE in 1 CARTON (68462-355-94) / 100 g in 1 TUBE1 tube2016-09-130000-00-00NoNoCurrent